Abstract | BACKGROUND: METHODS: We conducted a multicenter, single-arm, open-label phase III study in 56 patients with T2D and UACR ≥ 300 mg/g creatinine with estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 and treated with a renin-angiotensin system inhibitor. Patients received esaxerenone for 28 weeks at 1.25 mg/day initially with titration to 2.5 mg/day based on serum potassium (K+) monitoring. Efficacy was evaluated as the change in UACR from baseline to week 28. Safety endpoints included adverse events (AEs), incidence of serum K+ increase, and change in eGFR from baseline. RESULTS: UACR decreased by 54.6% (95% CI 46.9%, 61.3%) on average from baseline (544.1 mg/g creatinine) to the end of treatment (246.8 mg/g creatinine); 51.8% of patients showed improvement to early nephropathy. AE incidence was 69.6%. Three patients (5.4%) had serum K+ levels ≥ 6.0 mEq/L or ≥ 5.5 mEq/L on two consecutive occasions. Hyperkalemia in two patients was transient and resolved during the treatment period. One patient discontinued following two consecutive serum K+ values ≥ 5.5 mEq/L. The maximum change from baseline in eGFR was - 8.3 mL/min/1.73 m2 at week 24. CONCLUSIONS: CLINICAL TRIAL REGISTRATION: JapicCTI-173696.
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Authors | Sadayoshi Ito, Naoki Kashihara, Kenichi Shikata, Masaomi Nangaku, Takashi Wada, Yasuyuki Okuda, Tomoko Sawanobori |
Journal | Clinical and experimental nephrology
(Clin Exp Nephrol)
Vol. 25
Issue 10
Pg. 1070-1078
(Oct 2021)
ISSN: 1437-7799 [Electronic] Japan |
PMID | 34110524
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)
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Copyright | © 2021. The Author(s). |
Chemical References |
- Mineralocorticoid Receptor Antagonists
- Pyrroles
- Sulfones
- Creatinine
- esaxerenone
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Topics |
- Aged
- Albuminuria
(drug therapy, etiology, urine)
- Creatinine
(urine)
- Diabetes Mellitus, Type 2
(complications)
- Diabetic Nephropathies
(complications, drug therapy, urine)
- Female
- Glomerular Filtration Rate
- Humans
- Hyperkalemia
(chemically induced)
- Japan
- Male
- Middle Aged
- Mineralocorticoid Receptor Antagonists
(adverse effects, therapeutic use)
- Pyrroles
(adverse effects, therapeutic use)
- Sulfones
(adverse effects, therapeutic use)
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